Qc Stability Coordinator

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Regular Full-Time Non-Exempt Largo, FL, US

2 days ago Requisition

The QC Stability Coordinator authors stability protocols and performs the scheduling, sample-control, documentation, testing coordination, and Quality Management System event- activities required to execute stability studies at Formulated Solutions. The position is accountable for completing assigned stability tasks accurately and on time, maintaining traceable sample inventories and study records, and escalating risks before approved pull windows, testing deadlines, or reporting commitments are missed.

The coordinator works closely with Quality Operations, Manufacturing, the Innovation and Development Group, the Quality Control Laboratory, and Quality Assurance to define study requirements, obtain required technical information and samples, coordinate testing, resolve execution issues, and maintain study timelines.

This is an individual contributor role reporting to the Stability Supervisor. The coordinator executes approved protocols and procedures and does not independently approve protocols, change study requirements, establish shelf life, disposition OOS or OOT results, release product, or supervise employees.

• Author batch-specific stability protocols and protocol amendments using approved templates and applicable product, process, packaging, specification, test-method, storage-condition, and regulatory requirements.
• Route protocols and amendments to the Stability Supervisor and required cross‑functional reviewers for technical review and approval before study initiation or implementation of a change.
• Resolve review comments with Quality Operations, Manufacturing, the Innovation and Development Group, the Quality Control Laboratory, and Quality Assurance and maintain traceability of required revisions and approvals.
• Create study folders, trackers, labels, pull schedules, and data‑entry records from approved stability protocols.
• Assign stability study identification numbers in accordance with the approved procedure and verify that the product, lot, package configuration, storage condition, intervals, tests, specifications, and required sample quantities agree with the approved protocol.
• Calculate routine sample quantities using approved test methods and protocol requirements and submit calculations to the Stability Supervisor or designee for review.
• Identify incomplete, conflicting, or unclear protocol requirements before samples are placed on study; do not make undocumented assumptions or independently alter study requirements.
• Maintain current controlled copies of protocols, amendments, specifications, methods, and associated study records.

• Receive stability samples, verify identity and quantity, inspect package condition, document receipt, and reconcile discrepancies before study placement.
• Label samples and place them in the correct qualified chamber, storage condition, shelf, bin, and orientation specified by the approved protocol.
• Enter and maintain the exact chamber location and quantity for each sample in the approved inventory system or controlled tracker.
• Perform scheduled physical inventory reconciliations and document the result. Immediately escape missing, excess, damaged, leaking, mislabeled, or incorrectly located samples.
• Maintain chain of custody for all sample movements, temporary removals, transfers, shipments, returns, and authorized destruction.
• Prepare completed or discontinued study samples for…